FDA Resolves Compliance Issues with Drug/Device Combination Products

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FDA Resolves Compliance Issues with Drug/Device Combination Products

Drug/device combination products raise compliance and regulatory issues in the pharmaceutical industry. On their own, each drug and device has their own specific type of marketing and good manufacturing practices regulation. However, when drugs and devices are combined together, they pose a new compliance question – how will this new combined product be regulated as a whole? Pharmaceutical consultants point out there isn’t one easy solution.
 
Combination products consist of the following:  products that are combined with two or more regulated drugs, devices or biologics (i.e. drug/device, biologic/drug, or drug/device/biologic). Because of the diversity of these drug/device combinations, a one-size-fits-all approach doesn’t always work. For example, these drug/device products may consist of either drugs packaged along with devices, or the drugs coated on devices. Another combination is drugs and devices that are packaged separately. These separate drugs and devices may be produced by different manufacturers.
 
Another issue that arises is the complexity of drug/device combinations. Combined products could be as simple as a syringe pre-filled with drugs. They also could be as complex as chemotherapeutic drugs combined with monoclonal antibodies.
 
The U.S. Federal Drug Administration (FDA) has made it a top priority to address these ongoing compliance issues. They developed the Office of Combined Products (OCP) which was a result of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The OCP has taken the mystery out of the compliance process for drug/device combinations, and has proved successful.
 
The OCP’s main priority is to ensure that these combined products are sent to the appropriate FDA Centers. They oversee timely premarket reviews of combination products. The OCP also oversees consistent, effective post-market regulations.
 
However, OCP doesn’t handle the entire process associated with drug/device combination product compliance. They first determine the drug/device product’s “primary mode of action.” The OCP analyzes what is the “most important therapeutic action of a combination product.” Based on this “primary mode of action,” the OCP directs these drug/device products to the following Centers based on their analysis.  The responsibility lies on the following FDA centers: Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).
 
Because of the regulatory complications associated with combination products, the FDA created an effective way to handle this problem. The OCP wrote a SOP for IntercenterConsultative/Collaborative Review Process. It outlines the necessary procedures and processes that the three Centers must follow when reviewing combination products.
 
The FDA also consults with applicants and assists them with marketing applications. According to the FDA, single marketing applications for combination products usually work for clearance. Dependent upon the combination product, the FDA may recommend two separate marketing applications. The FDA advises applicants to contact the OCP to discuss the appropriate marketing application based upon their drug/device combination.
 
Pharmaceutical consultants agree that the FDA’s OCP has made great strides over the past few years with compliance issues for drug/device products. The OCP conducts trainings for both staff and applicants throughout the year to resolve combination product issues.
 
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Rachel Clarkson
Pharmaceutical consultants